Army of Women FAQ
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Project Title Shift Work and Breast Cancer Risk Study
Researcher Carla Finkielstein, PhD, Virginia Polytechnic Institute and State University, Blacksburg, VA
Study Summary The research team is studying breast tissue samples from women who have not had breast cancer, who have worked either day shifts or night shifts for at least five consecutive years to better understand whether wake/sleep cycle disruptions may increase breast cancer risk. Later, the researchers will compare the samples collected from women who have not had breast cancer to breast tissue samples collected from women with breast cancer.
Who Can Participate? You can join the Shift Work and Breast Cancer Risk Study if you match ALL of these MAIN categories:
• You are a woman between 30-65 years old
• You have never been diagnosed with breast cancer (including DCIS) (it is OK if you have a history of other cancers)
• You do not have the BRCA1 or BRCA2 mutation (if known; if you do not know, you can still participate in the study)
• At some point in your life, you have worked at least three night shifts per month for a period of at least 5 years in a row.
• You are able to go to the Susan G. Komen for the Cure Tissue Bank at the IU Simon Cancer Center in Indianapolis, IN, on September 21, 2013, for the core biopsy procedure
• You have never had a breast reduction or breast implants
• You are NOT allergic to local anesthetics (numbing medicine)
• You are NOT receiving a therapeutic blood thinner (this does NOT include aspirin)
• You have NOT undergone a total abdominal hysterectomy (removal of the ovaries and uterus)
• You are NOT currently pregnant or were pregnant within the last 12 months
• You are NOT currently lactating or have lactated within the last 12 months
• You understand that if you are eligible and choose to join this study, you are agreeing to participate in both the Shift Work and Breast Cancer Risk Study AND the Komen Tissue Bank. Some of your tissue sample will be sent to Dr. Finkielstein and the rest will be stored at the Komen Tissue Bank
• You understand that you will be asked to complete two Consent Form documents: one for the Shift Work and Breast Cancer Risk Study and one for the Komen Tissue Bank
• You understand that you will be asked to complete two questionnaires: one for the Shift Work and Breast Cancer Risk Study and one for the Komen Tissue Bank
After you RSVP, the research team will ask you additional questions to be sure that this study is a right fit for you.
What Does Participation Involve? If you join the Shift Work and Breast Cancer Risk Study you will be contacted by phone to answer questions about your health and work history. If you are eligible for the study and decide to participate, you will receive an email with a link to the online informed consent document. If you submit the signed consent document, you will be asked to complete a questionnaire about your work history, your shift work, your sleep patterns, factors that contribute to stress in your life, your job satisfaction, family medical history, and additional background information. You will receive and return the questionnaire in the mail (at no cost to you). After reviewing the completed questionnaires, the research team will choose the women who they will ask to provide breast tissue samples.
To collect the tissue samples, the researcher and the Army of Women are collaborating with the Susan G. Komen for the Cure Tissue Bank at the Indiana University Simon Cancer Center in Indianapolis. If you are chosen to participate and you choose to provide a breast tissue sample, you will be asked to attend a tissue collection event at the Komen Tissue Bank in Indianapolis, Indiana, on Saturday, September 21, 2013. In addition to donating tissue for this study, you will also be asked to donate tissue and a blood sample to be included in the Komen Tissue Bank for future studies not related to this specific study.
The Komen Tissue Bank obtains and stores specimens (tissue, blood, urine, or saliva) for researchers to use in their breast cancer studies. Just as the Army of Women serves as a resource for researchers looking for women, the Komen Tissue Bank is a resource for any researcher looking for healthy tissue sample. When you arrive at the Komen Tissue Bank, you will be asked to complete a separate Consent Form document and questionnaire for the Komen Tissue Bank.
A breast surgeon will perform approximately 4 core breast biopsies, removing cells from your breast with a needle under local anesthesia. This is an outpatient procedure and usually takes about 30 minutes. One of the tissue samples will be sent to Dr. Finkielstein for her analyses related to this study and the remaining samples will be stored at the Komen Tissue Bank. You will also be asked to donate a blood sample for the Komen Tissue Bank.
Please note: In order to participate in this study, you will need to agree to provide breast tissue samples that will be shared between this study and the Komen Tissue Bank. You can learn more about the Komen Tissue Bank at https://komentissuebank.iu.edu.
The researchers need to enroll approximately 50 women into the study (~25 day-shift works and ~25 night-shift workers). They have enrolled all of the day-shift workers and are currently recruiting for night-shift workers only.
Where? IU Simon Cancer Center, Indianapolis, Indiana